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Celcuity (CELC) investor relations material
Celcuity Q3 2025 earnings summary
Complete event summary combining all related documents: earnings call transcript, report, and slide presentation.Q3 2025 earnings summary12 Nov, 2025
Executive summary
Achieved major clinical and regulatory milestones, including positive Phase 3 VIKTORIA-1 results for gedatolisib in HR+/HER2- advanced breast cancer, completion of PIK3CA mutant cohort enrollment, and FDA acceptance of NDA submission under RTOR for the wild-type cohort, with final submission expected in Q4 2025.
Enrollment completed for both PIK3CA wild-type and mutant cohorts in VIKTORIA-1; topline data for the mutant cohort expected in late Q1 or Q2 2026.
Strengthened balance sheet through $287 million in net proceeds from offerings, expanded term loan facility to $500 million, and warrant exercises, providing funding through 2027.
Phase 1b/2 trial in metastatic castration-resistant prostate cancer ongoing, with promising early efficacy and safety data.
Commercial launch preparations for gedatolisib are well underway, with most hiring complete except for field sales.
Financial highlights
Q3 2025 net loss was $43.8 million ($0.92/share), up from $29.8 million ($0.70/share) in Q3 2024; non-GAAP adjusted net loss was $37.2 million ($0.78/share) vs. $27.6 million ($0.65/share) year-over-year.
Operating expenses for Q3 2025 rose to $42.8 million from $30.1 million in Q3 2024, driven by higher R&D and G&A costs.
R&D expenses were $34.9 million, up 27% year-over-year; G&A expenses were $7.9 million, up 221%.
Cash, cash equivalents, and short-term investments totaled $455 million as of September 30, 2025.
No revenue generated to date; company remains pre-commercial.
Outlook and guidance
Cash, investments, and available debt expected to fund operations through 2027.
Topline data for the PIK3CA mutant cohort of VIKTORIA-1 expected in late Q1 or Q2 2026.
NDA submission for gedatolisib targeted for Q4 2025.
Anticipates increased R&D and G&A expenses as clinical programs advance and commercialization preparations continue.
Peak revenue for gedatolisib in second-line wild-type indication estimated at $2.5–$3 billion, with a total addressable market of $5–$6 billion.
Gedatolisib triplet's incremental PFS benefit?
Detail launch prep R&D expense increase.
mCRPC study: 6-month rPFS rate for combined arms?
What supports majority market share confidence?
Implications of separate wild-type/mutant NDA?
Prioritize funding for multiple indications?
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Evercore ISI 8th Annual HealthCONx Conference3 Dec, 2025
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Frequently asked questions
Celcuity Inc. is a biotechnology company focused on developing diagnostic tests to improve the treatment of cancer. The company specializes in functional cellular analysis, using its proprietary CELsignia platform to identify molecular and cellular changes in a patient’s cancer cells. This technology helps detect new cancer subtypes and matches patients with targeted therapies that are most likely to be effective. The company is headquartered in Minneapolis, Minnesota, and its shares are listed on the NASDAQ.
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